Systems, methods and devices for connecting non-adherent structures

ABSTRACT

A system for forming an anastomosis between first and second sections of a digestive tract includes Optical Scope Device (“OSD”) having a lumen extending therethrough and positioned at a first target site within the first section, OSD including an imaging component at a distal end thereof for viewing the first target site; First Endoscope (“FE”) including a working channel extending therethrough and positioned at a second target site within the second section; Capture Device (“CD”) extending from a proximal end to a distal end including a loop, CD extends through the lumen; First Flexible Element (“FFE”) extends through FE, FFE including a coupling element which passes through the loop to couple FFE to CD, connecting the first and second sections, the coupling element moving between insertion and locking configurations; and Stent having a lumen extending therethrough which provides fluid communication between the first and second sections.

PRIORITY CLAIM

This application is a continuation of Ser. No. 16/244,859, filed Jan.10, 2019, and claims the benefit of priority under 35 U.S.C. § 119 to,U.S. Provisional Application Ser. No. 62/616,217, filed Jan. 11, 2018,the disclosures of which are herein incorporated herein by reference intheir entirety.

FIELD OF THE INVENTION

The present invention relates to systems, methods and devices forsuturing organs of human body and more specifically with systems,methods and devices for performing gastroenteral anastomoses.

BACKGROUND

Gastroenteral anastomoses have been performed to treat malnutritionassociated with gastric outlet obstruction as well as other issues. Agastroenteral anastomosis may be created surgically, eitherlaparoscopically or through an open surgical procedure. However,performing this procedure endoscopically entails many challengesincluding the need to endoscopically locate a desired position in thesmall bowel via the gastric lumen. Although ultrasound endoscopes havebeen used to provide images through the gastric and enteral walls, thesmall bowel is typically deflated and difficult to access in thismanner.

Techniques for alleviating this targeting challenge have included usinga tracking balloon passed through the pylorus deep into the duodenum orthe proximal portion of the jejunum near the ligament of Trietz. Thetargeting balloon is then inflated with contrast medium or with water orair which provide clearer visualization by ultrasound endoscopy and/orfluoroscopy. A second method employs two similarly sized balloonsaxially separated from one another (i.e., along a longitudinal axis ofthe device) by approximately 200 mm. A space within the device extendingbetween these balloons is then filled with dilute contrast mediumcreating a target for the puncture from the gastric lumen. An advantageof the two-balloon method is that the balloon itself is not punctured,as is the case with a single target balloon because the physician ispuncturing between the balloons and not directly into either of them.Another method includes flooding the small bowel with diluted contrastto distend and visualize the small bowel. When the small bowel ispharmaceutically immobilized, a temporary target is created. But overtime the fluid dissipates and needs to be reintroduced.

A second challenge posed by endoscopic gastroenterostomy is thepotential to lose control of a distal portion of the tissue after theinitial penetration has been made. This may become more serious if theinitial puncture site has been dilated with either a balloon orelectrocautery.

SUMMARY

The present disclosure relates to a system for forming an anastomosisbetween first and second sections of a digestive tract comprising anoptical scope device including a lumen extending therethrough configuredto be positioned at a first target site within the first section, theoptical scope device including an imaging component at a distal endthereof for viewing the first target site and a first endoscopeincluding a working channel extending therethrough configured to bepositioned at a second target site within the second section incombination with a capture device extending from a proximal end to adistal end including a loop, the capture device configured to extendthrough the lumen of the optical scope device and a first flexibleelement configured to extend through the first endoscope, the firstflexible element including a coupling element at a distal end thereof,the coupling element being configured to be passed through the loop tocouple the first flexible element to the capture device, connecting thefirst and second sections, the coupling element being movable between aninsertion configuration in which the coupling element is sized to passthrough the loop of the capture device and an locking configuration inwhich the coupling element is configured to prevent the expandableelement from passing through the loop, removably locking the firstflexible element wire to the capture device. The system also includes astent including a body portion, a proximal flange and a distal flange,the body portion including a lumen extending therethrough and configuredto extend through walls of the first and second target sites so that thelumen provides fluid communication between the first and secondsections.

In an embodiment, the system further includes a stent delivery systemincluding a catheter extending from a distal end to a proximal endcoupled to a handle, the catheter including a working channel configuredto receive the stent therein, the stent delivery system configured toposition the stent within the target anastomosis site.

In an embodiment, the first section is within the small intestine.

In an embodiment, the second section is within the stomach.

In an embodiment, the system further includes a needle positioned withinthe working channel of the first endoscope, the needle including a lumenextending therethrough and configured to be advanced through the wallsof the first and second target sites until a distal end thereof,positioned within the second section of the digestive tract, ispositioned within the loop, the lumen configured to receive the firstguide wire.

The present disclosure also relates to a method for forming ananastomosis between a first section of the digestive tract and a secondsection of the digestive tract. The method includes advancing an opticalscope device including a lumen extending therethrough to a first targetsite within the first section of the digestive tract, the optical scopedevice including an imaging component at a distal end thereof forviewing the first target site, advancing a first endoscope including aworking channel extending therethrough to a second target site withinthe second section of the digestive tract, coupling a first guide wireextending through the first endoscope to a capture device extendingthrough the optical scope device to connect the first and secondsections of the digestive tract, the first guide wire being passed fromthe first section to the second section through walls of the first andsecond target sites, the imaging component providing a visual feed ofthe first target site to facilitate the coupling of the first guide wireand capture device, positioning the stent in a target anastomosis siteso that a distal flange of the stent is positioned within the firstsection, a proximal flange is positioned within the second section, anda body portion bridges the walls of the first and second target sites, alumen of the body portion allowing for fluid communication between thefirst and second sections.

In an embodiment, the capture device is a snare device.

In an embodiment, the method further includes inserting the snare devicethrough the lumen of the optical scope device until a distal end thereofextends distally past the distal end thereof, the snare device includinga distal loop configured to be movable between an expanded configurationand a tightened configuration.

In an embodiment, the method further includes advancing a needle fromthe working channel of the first endoscope through a wall of the firsttarget site and a wall of the second target site until a distal endthereof, positioned within the second section of the digestive tract, ispositioned within the loop.

In an embodiment, the method further includes inserting the first guidewire through a lumen of the needle until a distal end of the guide wireextends through the loop and tightening the loop around the first guidewire to create a connection between the first and second sections.

In an embodiment, the method further includes infusing a volume ofliquid into the first target site to increase the diameter of the firstsection and provide an image of the target lumen via ultrasound toassist a user visualizing the first target site.

In an embodiment, the stent is positioned within the target anastomosissite via a stent delivery system, the stent delivery system including acatheter extending from a distal end to a proximal end coupled to ahandle, the catheter including a working channel configured to receivethe stent therein.

In an embodiment, the method further includes passing the distal end ofthe catheter through the walls of the first and second target sites,deploying the distal flange of the stent so that the distal flange abutsthe wall of the first target site within the first section, retractingthe catheter through the walls of the first and second target sites to aposition within the second section and deploying the proximal flange ofthe stent so that the proximal flange abuts a wall of the second targetsite within the second section.

In an embodiment, a distal end of the guide wire includes an anchorportion, the anchor portion extending perpendicular to a longitudinalaxis of the first guide wire to form a T-shape.

In an embodiment, the method further includes advancing a secondendoscope including a working channel extending therethrough to thefirst section, passing a second guide wire through the working channelof the second endoscope until a distal end thereof is positioned at thefirst target site, withdrawing the second endoscope from the patient,advancing the optical scope device over the second guide wire to thefirst target site and withdrawing the second guide wire from thepatient.

The present disclosure also relates to a method for forming ananastomosis between a first section of the digestive tract and a secondsection of the digestive tract. The method includes determining a firsttarget site within a first section of the digestive tract via an imagingcomponent of an optical scope device, the imaging component providing auser with a visual feed of the first target site, the optical scopedevice including a lumen extending therethrough and having a distal endpositioned at the first target site, determining a second target sitewithin a second section of the digestive tract via an ultrasoundendoscope, the ultrasound endoscope including a working channel andhaving a distal end positioned at the second target site, forming aconnection between the first and second sections of the digestive tractby passing a distal end of a guide wire from the ultrasound endoscopethrough the second target site to the first target site through walls ofthe first and second target sites until the distal end is positionedwithin a capture mechanism extending from the optical scope device, thecapture mechanism being positioned at the first target site anddeploying a stent over the guide wire so that a distal flange of thestent is positioned within the first section, a proximal flange ispositioned within the second section, and a body portion bridges thewalls of the first and second target sites, a lumen of the body portionallowing for fluid communication between the first and second sections.

In an embodiment, the method further includes transilluminating thefirst and second target sites through walls of the first and secondtarget sites via a light source at the distal end of the optical scopedevice to assist a user in visualizing the desired location of theanastomosis.

In an embodiment, the method further includes providing the user with anultrasound image, via the ultrasound endoscope, of the transillumintatedfirst and second target sites.

BRIEF DESCRIPTION

FIG. 1 depicts a perspective view of an endoscope of a system and methodaccording to an exemplary embodiment of the present disclosure;

FIG. 2 depicts a schematic, partially cross-sectional view of an opticalscope device of a system and method of FIG. 1;

FIG. 3 depicts a schematic, partially cross-sectional view of anultrasound endoscope of the system and method of FIG. 1;

FIG. 4 depicts a perspective view of a snare device according to anexemplary embodiment of the system and method of FIG. 1;

FIG. 5 depicts a partially cross-sectional view of a stent deliverysystem of the system and method of FIG. 1;

FIG. 6 depicts a perspective side view of a stent of the system andmethod of FIG. 1;

FIG. 7 depicts a partially cross-sectional view of a method step forforming an anastomosis according to an exemplary embodiment of thepresent disclosure;

FIG. 8 depicts a partially cross-sectional view of a method step forforming an anastomosis;

FIG. 9 depicts a partially cross-sectional view of a method step forforming an anastomosis;

FIG. 10 depicts a partially cross-sectional view of a method step forforming an anastomosis;

FIG. 11 depicts a partially cross-sectional view of a method step forforming an anastomosis;

FIG. 12 depicts a partially cross-sectional view of a method step forforming an anastomosis;

FIG. 13 depicts a partially cross-sectional view of a method step forforming an anastomosis;

FIG. 14 depicts a partially cross-sectional view of a method step forforming an anastomosis;

FIG. 15 depicts a partially cross-sectional view of a method step forforming an anastomosis;

FIG. 16 depicts a partially cross-sectional view of a method step forforming an anastomosis; and

FIG. 17 depicts a perspective view of T-wire extension for a guide wireof the system and method of FIG. 1.

DETAILED DESCRIPTION

The present disclosure may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The present disclosurerelates to a system and method for endoscopically connectingnon-adherent structures. Specifically, the present disclosure relates toa system and method for creating a gastroenteral anastomosis. Exemplaryembodiments of the present disclosure describe a system including anoptical scope device which provides direct visual access at the targetsite within the small intestine. The exemplary system also includes anultrasound endoscope for visualizing a target site (e.g., within thestomach), as well as a guide wire system for connecting the opticalscope device and the ultrasound endoscope through the walls ofintervening organs (e.g., the stomach and the small intestine). Itshould be noted that the terms “proximal” and “distal” as used hereinare intended to refer to a direction toward (proximal) and away from(distal) a user of the device.

As shown in FIG. 1, a system 100 includes an endoscope 110 including anelongate member 111 extending from a proximal end 115 to a distal end113 and including a working channel 108 extending therethrough. Theelongate member 111 is flexible, or can include a portion that isflexible, as would be understood by those skilled in the art, to allowthe elongate member to be maneuvered along a tortuous path within, forexample, a natural body lumen. As will be described in further detailbelow, the system 100 also includes an optical scope device 114, anultrasound endoscope 116, a snare device 118, and a stent system 122.

In an exemplary embodiment shown in FIG. 2, the optical scope device 114is a direct visualization scope such as, for example, a Spy Scope™ thatallows the user to view the small intestine when the distal end of theoptical scope device 114 has been inserted therein. The optical scopedevice 114 includes an elongate member 126 that can be inserted into abody lumen, a distal scope tip 128, and a handle that remains outsidethe body lumen when the scope is in use. As would be understood by thoseskilled in the art, the handle includes one or more control mechanismsor actuators that can be used to control and maneuver the elongatemember 126 of the optical scope device 114 within the body lumen. Theoptical scope device 114 may also include an actuator that may be usedto actuate other functions of the endoscope 20, such as to control ormaneuver lenses, image detectors and/or other components associated withilluminating and/or capturing images within a body lumen. As would beunderstood by those skilled in the art, the distal tip 128 may becoupled to or integrally formed with a distal end portion of theelongate member 126. The distal scope tip 128 includes a housing 130encasing imaging and/or optical components 133. For example, opticalcomponents, such as one or more lenses, an image detector, and/or alight source may be at least partially encased or embedded within thehousing 130. The optical scope device 114 may also include one or morelumens 132 extending through the elongate member 126 and/or the handle.In some embodiments, the elongate member 126 of the optical scope device114 includes a single lumen 132 through which various components may beinserted to the target area. For example, the optical scope device 114may include one or more working channels or lumens 132 sized and shapedto slidably receive various medical devices or tools, such as, forexample, the guide wire 112, irrigation and/or suction devices, forceps,drills, snares, needles, etc.

A system controller 134 may be coupled to the optical scope device 114and configured to control various elements of the optical scope device114 as described in more detail below. As would be understood by thoseskilled in the art, the system controller 134 may include, for example,a processor 136, an image controller 138, and a light controller 140.The light controller 140 may include, for example, an external lightsource providing light to a distal end of the optical scope device 114to illuminate target tissue to be imaged by the optical scope device114. The image controller 138, the processor 136 and/or the lightcontroller 140 may be coupled to an image or video display device 142(e.g., a computer, a monitor or other known image display device) viathe system controller 134 or by a separate connection. In alternativeembodiments, some or all of these devices may be provided as separatecomponents, separate from the system controller 134.

As can be seen in FIG. 3, the ultrasound endoscope 116, in thisembodiment, is a flexible endoscope extending from a proximal end to adistal end and including a working channel 148 extending therethrough.In an embodiment as would be understood by those skilled in the art, theultrasound endoscope 116 may include forward and/or oblique viewingoptics 149 adjacent to the distal end 151 of the working channel forviewing the area adjacent to the open distal end of the working channel148. The ultrasound endoscope 116 also includes an ultrasonic transducer150 at its distal end for providing an ultrasonic image of the stomachwall and surrounding area. A needle 120 is housed within the workingchannel 148 of the ultrasound endoscope 116. The needle 120, in anembodiment, is substantially cylindrical (although any other suitableshape may be employed) and extends from a proximal end to a sharp,tissue penetrating distal point 154. A lumen 153 extends through theneedle 120 to a distal opening 152 at the distal point 154. The needle120 is longitudinally movable with respect to the ultrasound endoscope116 between a retracted or insertion position in which a distal end ofthe needle 120 is fully housed within the working channel 148, as shownin FIG. 13, and an extended position in which the needle 120 extendsdistally past the distal end of the working channel 148, as shown inFIG. 5. The ultrasound endoscope 116 may be connected to the systemcontroller 134, processor 136 and display device 142 as would beunderstood by those skilled in the art.

The snare device 118, according to an exemplary embodiment depicted inFIG. 4, includes a flexible elongate member 158 and the distal loop 156.The snare device 118 is designed to ensnare a needle or guide wire inproximity to the distal loop 156 of the snare device 118 and to becontrolled by a user manipulating the elongate member 158. The elongatemember 158 extends from the distal loop 156 to a proximal end whichremains outside the body accessible to the user of the device andincludes an actuator or other means for controlling the loop 156. Forexample, in an embodiment, the elongate member 158 may include a handle.The snare device 118 is adapted to be passed into the lumen 132 of theoptical scope device 114 to the desired position within the smallintestine. The elongate member 158 preferably has a diameter smallerthan that of the optical scope device lumen 132 through which it ischanneled such that the loop 156 may pass with relative ease through thelength of the optical scope device 114, and exit the distal end thereof.The loop 156 is expandable from an insertion configuration in whichlateral portions of the loop are pressed together by the inner wall ofthe lumen 132 of the optical scope device 114 and an open configuration,shown in FIG. 5, in which lateral portions separate from one another(e.g., under a bias imparted to the material of the loop 156) to form anopen loop—e.g., substantially circular, elliptical, etc. In someembodiments, the snare device 118 may be made from a shape memorymaterial such as a shape memory alloy, for example, nickel titanium,also known as nitinol, or a shape memory polymer, to allow the loop 156to easily move between the insertion and open configurations. The loop156 is also capable of being tightened by the user to capture the tipof, for example, the needle 120, as will be described in further detailbelow. The snare device 118 and loop 156 may be rotated within theendoscope's instrument insertion channel by manipulating the proximalend (not shown in this embodiment) of the snare device 118 to modify theposition and orientation of the loop 156 relative to the target deviceto be captured therein.

The system further includes a stent delivery system 122 such as, forexample, the AXIOS Stent System™ available from Boston Scientific Corp.The stent delivery system 122, as shown in FIG. 5, includes a catheter166, with the stent 164 disposed therein, and a handle 168. As can beseen in FIG. 6, the stent 164 is configured as a tubular body 172 withproximal 174 and distal 176 flanges and a central lumen 178. In anexemplary embodiment, the catheter 166 may also include a cautery distaltip 170 which aids in creating a hole in the stomach and small intestinewalls for insertion of the catheter 166 and, subsequently, the stent164.

FIG. 7 depicts part of a method for forming an anastomosis between afirst portion 102 of the digestive tract and a second portion 104 of thedigestive tract. In the depicted embodiments, the first portion 102 isgenerally depicted as the stomach 103, while the second portion 104 isdepicted as a portion of the small intestine 105 to perform, forexample, a gastrojejunostomy to bypass the duodenum or other portion ofthe small intestine. It will be understood that while the presentembodiments depict the first portion 102 as the stomach 103 and thesecond portion 104 as the small intestine 105, the anastomosis may beformed between any other suitable portions of the digestive tract. Forexample, an anastomosis may also be formed between the stomach and thelarge intestine or between a portion of the small intestine and aportion of the large intestine.

As shown in FIG. 8, the endoscope 110 is passed through the mouth of thepatient, along the esophagus, through the patient's stomach 103, throughthe pylorus and into the small intestine 105. The guide wire 112 is thenpassed down the working channel 108 of the endoscope 110 until thedistal end 124 of the guide wire 112 exits the endo scope 110 andextends into the duodenum distally beyond the ligament of Treitz. Oncethe guide wire 112 is in a target position, the endoscope 110 is removedfrom the patient leaving the guide wire in the small intestine with thedistal end 124 at the desired position therein. As seen in FIG. 8, theelongate optical scope device 114 is then advanced over the guide wire112 into the small intestine.

It will be understood by those skilled in the art that once the opticalscope device 114 has been advanced to a distal end of the guide wire 112beyond the ligament of Trietz, the optical scope device 114 and theguide wire 112 may be advanced to the target anastomosis site 104 by anumber of methods. For example, in one embodiment, the optical scopedevice 114 and the guide wire 112 are advanced simultaneously as a unitthrough the small intestine 105 to the target anastomosis site 104. Inanother embodiment, the guide wire 112 is advanced ahead of the opticalscope device 114 which is then followed over the guide wire 112,repeating until both arrive at the desired location within the smallintestine.

With the optical scope device 114 and the guide wire 112 at the targetanastomosis location, the ultrasound endoscope 116 is introduced intothe patient along the optical scope device 114 through the mouth andinto the stomach. The distal end 144 of the ultrasound endoscope 116,instead of being allowed to exit the stomach via the pylorus, isdirected to the side of the stomach 102 adjacent to a target site forthe anastomosis. Specifically, the ultrasound endoscope 116 is leanedagainst the lower portion of the greater curvature of the stomach 103 tolook through the gastric wall toward the small intestines, as shown inFIGS. 9-10.

In order to assist with visualization of the location of the guide wire112 and the optical scope device 114 within the small intestine 105 andthus, the desired location of the anastomosis connection 104, the usermay infuse a volume of fluid into the small intestine 105 through thelumen 132 of the optical scope device 114. The fluid increases thediameter of the small intestine in the region where the tip 128 of theoptical scope device 114 is located so that the user can easilyvisualize the anastomosis location 104. In one embodiment, a radiopaquefluid may be used, allowing the user to employ fluoroscopy to visualizethe desired region 104 of the small intestine 105. The user may also usethe light source 133 of the optical scope device 114 to transilluminatethe small intestine 105 and the stomach 103 to allow the ultrasoundendoscope 116 to see the direction of the desired connection to be made.Alternatively, the user may use a light provided on the ultrasoundendoscope 116 to transilluminate the stomach 103 and the small intestine105 to be visualized by the camera on the optical scope device 114.

With the ultrasound endo scope 116 in position within the stomach, theguide wire 112 may then be withdrawn from the lumen 132 of the opticalscope device 114 and out of the patient, as shown in FIG. 10. The snaredevice 118 is then inserted through a lumen 132 of the optical scopedevice 114 until a loop 156 at a distal end of the snare device 118extends distally past the distal tip 128 of the optical scope device 114into the fluid in an open position. As those skilled in the art willunderstand, if there is sufficient room in the lumen 132, the guide wire112 may alternatively be left in place as the snare device 118 isinserted therethrough.

Turning to FIG. 11, the first portion 102 and the second portion 104 canbe seen in more detail. An anastomosis is to be formed between the firstand second portions 102, 104. The distal end of the flexible ultrasoundendoscope 116 is positioned adjacent to the stomach wall portion 102while the distal ends of the optical scope device 114 and snare 118 arepositioned adjacent to the small intestine second portion 104. When itis desired to commence formation of the anastomosis, the needle 120 isextended distally out of the working channel and pushed through thestomach wall at the first portion 102 and then through the smallintestine second portion 104. The distal end of the snare device 118 isthen manipulated by the user until the loop 156 is positioned around adistal portion of the needle 120. The loop 156 is then tightened aroundthe needle 120 via proximal movement of the elongate member 158.

In order to form a stable connection between the stomach 103 and thesmall intestine 105, a second guide wire 160 is inserted through thelumen 150 of the needle 120 until a distal end 162 of the guide wire 160extends distally out of the lumen 150 and into the small intestine 105,as can be seen in FIG. 11. When a desired amount of the guide wire 160has been advanced beyond the tip of the needle 120, as visualized by theoptical scope device 114, the snare loop 156 is loosed via distalmovement of the elongate member 158 and repositioned on the guide wire160, where the loop 156 is retightened to create a connecting railbetween the first and second portions 102, 104, as depicted in FIG.12-13. This stable connection provides the user with control from bothends of the anastomosis (i.e., from within the small intestine as wellas within the stomach). After the guide wire 160 has been successfullycaptured by the snare loop 156, the needle 120 may be retracted from thesmall intestine and the stomach through the working channel of theultrasound endoscope 116, leaving the guide wire 160 and snare device118 connected through the walls of the stomach and small intestine, asshown in FIG. 14.

In an exemplary embodiment, the guide wire 160 may include a balloon orother expandable element at a distal end thereof to prevent the snareloop 156 from sliding off after capture of the guide wire 160.Specifically, the snare loop 156 is positioned over the guide wire 160,proximally of the balloon. The balloon is then inflated with either afluid or a gas to a size larger than a size of the opening of the snareloop 156, preventing the loop 156 from disengaging from the guide wire160.

In another exemplary embodiment, the guide wire 160 includes a T-wireextension 161 at the distal end 162, as shown in FIG. 17. Specifically,the distal end includes an anchor portion 163 that extends perpendicularto a longitudinal axis, L, of the guide wire 160, forming a T-shape.When the guide wire 160 is positioned with the lumen 150 of the needle120, the anchor portion 163 is constrained to an insertion configurationin which the anchor 163 is substantially parallel to the guide wire 160.However, then the distal end 162 of the guide wire 160 is advanceddistally past the distal end of the needle 120, the extension 161 moves(e.g., under its natural bias) to its deployed configuration with theanchor portion 163 perpendicular to the guide wire 160. Thus, thisT-wire extension 161 with the anchor 163 prevents the snare frominadvertently sliding off of the guide wire 160.

With the connection in place, a stent 164 may be positioned at theanastomosis site using the stent delivery system 122. The catheter 166is advanced over the guide wire 160 through the working channel 148 ofthe ultrasound endoscope until the distal tip reaches the wall of thestomach 103, as shown in FIG. 15. At this point, if the catheter 166includes a cautery distal tip 170, the user may turn on the electricalenergy supply to the tip 170 so that as the catheter 166 is advanceddistally, a small hole is formed through the stomach and the smallintestine walls. The catheter 166 is advanced until visible by theoptical scope device 114 within the small intestine. Once the catheter166 is in a desired position at the site of the anastomosis, the distalflange segment 176 of the stent 164 is deployed from the distal end ofthe catheter 166 via an actuator on the handle 168 as would beunderstood by those skilled in the art. Once the distal flange 176 is inplace adjacent to the wall of the small intestine 105 at the targetportion 104, the catheter 166 is retracted, drawing the stomach andintestine walls together. The proximal flange 174 of the stent 164 isthen deployed within the stomach 103 at the target portion 102. Thus, atthis point the entire stent 164 is deployed with the distal flange 176within the small intestine 105, the proximal flange 174 within thestomach 103 and the tubular body 172 bridging the small intestine andstomach walls, as shown in FIG. 16. The flanges 174, 176 preventmigration of the stent 164 from the anastomosis point while maintainingtissue apposition between the stomach 103 and small intestine 105 whilethe lumen of the tubular body 172 allows for fluid communication betweenthe two organs.

With the anastomosis complete, the stent system 122 may be retracted outof the body. The snare loop 156 is then loosened and the guide wire 160and ultrasound endoscope 116 are removed from the body, followed by theoptical scope device 114 and snare device 118.

It will be appreciated by those skilled in the art that changes may bemade to the embodiments described above without departing from theinventive concept thereof. It should further be appreciated thatstructural features and methods associated with one of the embodimentscan be incorporated into other embodiments. It is understood, therefore,that this invention is not limited to the particular embodimentsdisclosed, but rather modifications are also covered within the scope ofthe present invention as defined by the appended claims.

What is claimed is:
 1. A system for forming an anastomosis between firstand second sections of a digestive tract, the system comprising: a firstelongate member having a working channel extending therethrough andconfigured to be extended to a target site within the first section; asecond elongate member having a working channel extending therethroughand configured to be positioned at a target site within the secondsection; a first flexible elongate member configured to extend throughthe working channel of the first elongate member and having a distal endwith a loop and a proximal end; and a first flexible element configuredto extend through the working channel of the second elongate member, andincluding a coupling element at a distal end thereof; wherein: thecoupling element is configured to be passed through the loop to couplethe first flexible element to the first flexible elongate member,thereby connecting the first and second sections; and the couplingelement is movable between a first configuration in which the couplingelement is sized to pass through the loop, and a second configuration inwhich the coupling element is configured to prevent the coupling elementfrom passing through the loop to removably lock the first flexibleelement to the first flexible elongate member to create a connectingrail between the first and second sections of the digestive tract. 2.The system of claim 1, further comprising a stent configured to extendthrough walls of the first and second target sites.
 3. The system ofclaim 2, wherein the stent comprises a body portion, a proximal flange,and a distal flange, the body portion including a lumen extendingtherethrough configured to provide fluid communication between the firstand second sections.
 4. The system of claim 2, further comprising astent delivery system including a catheter extending from a proximal endcoupled to a handle to a distal end positionable at the target sitewithin the second section, the catheter including a working channelconfigured to receive the stent therein, the stent delivery systemconfigured to position the stent within the target anastomosis site. 5.The system of claim 1, wherein: the distal end of the first flexibleelongate element is configured to extend to the target site within thefirst section; and the first flexible element is configured to extend tothe target site within the second section and to be passed through thesecond section to the first section to be coupled with the loop of thefirst flexible elongate member.
 6. The system of claim 1, wherein thefirst section is within the small intestine.
 7. The system of claim 1,wherein the second section is within the stomach.
 8. The system of claim1, further comprising: a needle positioned within the working channel ofthe second elongate member, the needle including a lumen extendingtherethrough and configured to be advanced through the walls of thefirst and second target sites until a distal end thereof, positionedwithin the second section of the digestive tract, is positioned withinthe loop, the lumen configured to receive the first flexible element. 9.The system of claim 1, wherein the first flexible element is a guidewireand wherein the coupling element is an expandable element which, in thefirst configuration, has a diameter greater than a diameter of the loopto prevent the coupling element from passing through the loop.
 10. Thesystem of claim 1, wherein the first elongate member is an optical scopedevice.
 11. The system of claim 10, further comprising an endoscopehaving a working channel extending therethrough and configured to beextended to a target site within the first section, wherein the opticalscope device is extended through the working channel of the endoscope tothe target site within the first section.
 12. The system of claim 1,wherein the second elongate member is an endoscope.
 13. The system ofclaim 1, wherein the coupling element at the distal end of the firstflexible element is a balloon.
 14. A system for forming an anastomosisbetween first and second sections of a digestive tract, the systemcomprising: a first elongate member having a working channel extendingtherethrough and configured to be extended to a target site within thefirst section; a second elongate member having a working channelextending therethrough and configured to be positioned at a target sitewithin the second section; a first flexible elongate member extendingthrough the lumen of the first elongate member and having a distal endwith a loop and a proximal end; and a first flexible element configuredto extend through the second elongate member and having a distal end anda proximal end; wherein: the loop is configured to be passed over thedistal end of the first flexible element to couple the first flexibleelongate member to the first flexible element, thereby connecting thefirst and second sections; and the loop is movable between a firstconfiguration in which the loop is sized to be positioned over thedistal end of the first flexible element, and a second configuration inwhich the loop is configured to capture the distal end of the firstflexible element to create a connecting rail between the first andsecond sections of the digestive tract.
 15. The system of claim 14,further comprising an expandable element at the distal end of the firstflexible element, the expandable element movable between a firstconfiguration in which the expandable element is sized to pass throughthe loop, and a second configuration in which the expandable element isprevented from passing through the loop to removably lock the firstflexible element to the first flexible elongate member to create aconnecting rail between the first and second sections of the digestivetract.
 16. The system of claim 15, wherein the expandable element is aballoon.
 17. The system of claim 16, further comprising a stentconfigured to extend through walls of the first and second target sites.18. A system for forming an anastomosis between first and secondsections of a digestive tract, the system comprising: a first elongatemember having a working channel extending therethrough and configured tobe extended to a target site within the first section; a second elongatemember having a working channel extending therethrough and configured tobe positioned at a target site within the second section; a firstflexible elongate member extending through the working channel of thefirst elongate member and having a proximal end and a distal end; and afirst flexible element extending through the working channel of thesecond elongate member and having a proximal end and a distal end;wherein: the distal end of the first flexible elongate member and thedistal end of the first flexible elongate member are configured to beconnected together to create a connecting rail between the first andsecond sections of the digestive tract.
 19. The system of claim 18,wherein the distal end of the first flexible elongate member includes aloop, and the distal end of the first flexible element includes anexpandable element, the loop and the expandable element connectable tocreate a connecting rail between the first and second sections of thedigestive tract.
 20. The system of claim 18, further comprising a stentconfigured to extend through walls of the first and second target sites.